FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating Epstein-Barr virus-...
The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs
FDA publishes a guidance on how it calculates combination product application user fees.
FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control i...
FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.
FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.
